In December 2011, the FDA issued a Drug Safety Communication concerning a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). Gilenya is the first approved Multiple Sclerosis pill, which was approved in 2010.
Based on the reported information, the FDA stated that a cause of death could not be identified. And, on the basis of the available data, a link between the first dose of Gilenya and the patient’s death could not be ruled out; however, there is not clear evidence that the drug played any role in the death.
But, due to the circumstances surrounding the patient’s death, the FDA re-evaluated clinical trial data related to the effects of Gilenya on heart rate and blood pressure, including data from trials that were ongoing at the time the drug was approved by FDA.
In light of the findings of the clinical trial data and postmarketing data, including all reported deaths of cardiovascular or unknown origin, FDA has revised the Gilenya drug label with specific recommendations for monitoring patients and with new contraindications for use of Gilenya in certain patients.
According to the latest Drug Safety Communication issued by the Food & Drug Administration (FDA), Gilenya is now contraindicated (FDA advises against its use) in patients with certain pre-existing or recent (within last 6 months) heart conditions or stroke. The agency also said Gilenya should not be prescribed to patients who are taking certain antiarrhythmic medications.
Based on the FDA analysis, the heart rate lowering affects of Gilenya can occur within six hours of taking the first dose, and as late as 20 hours after the first dose. As such, the agency is continuing to recommend that all patients starting Gilenya be monitored for signs of a slow heart rate (bradycardia) for at least 6 hours after the first dose. The agency is also now recommending hourly pulse and blood pressure measurement for all patients starting Gilenya. Electrocardiogram (ECG or EKG) testing should be performed prior to dosing and at the end of the observation period. Cardiovascular monitoring should continue until any symptoms resolve, the FDA said.
Lastly, the FDA is also recommending that cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia. These patients include:
- Patients who develop severe bradycardia after administration of the first dose of Gilenya
- Patients with certain pre-existing conditions in whom bradycardia may be poorly tolerated
- Patients receiving therapy with other drugs that slow the heart rate or atrioventricular conduction
- Patients with QT interval prolongation (a type of heart rhythm abnormality) prior to starting Gilenya, or at any time during the cardiovascular monitoring period
- Patients receiving therapy with other drugs that prolong the QT interval and that can cause a serious and life-threatening abnormal heart rhythm called Torsades de pointes